Pfizer

Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone

Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.

Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.

12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.

About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.

Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.

Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.

Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.

dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.

left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.

After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.

GI upset with lower abdominal cramping and pain the two mornings after receiving the vaccine. Worse on day 2. Improved with eating.

I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.

Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.

0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930: VS: BP: 145/90, P: 89; T: 98.3 DEG. F; 02 SAT: RA: 97%; 0948: VS: BP: 129/82, P: 85, O2 SAT: 98 %R.A.

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.

Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours

Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.

Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite

Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic

bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.

fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.

Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.

Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site

about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Fever, Headache. Stated that a few hours later she started with diarrhea

severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.

Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.

Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose

This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.

about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms resolved 48 hours post injection but had upset stomach and loose stool which persisted. 1st injection just had soreness at site and a mild headache

heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.

Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.

Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs

Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium

onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.

1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response

HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.

Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours Chills, blanket, intermittent over 24+ hours

Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.

I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.

muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on Jan2021. No treatment was given for the events. No follow-up attempts are possible. No further information is expected.

within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches

Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.

Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.

1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.

Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours

Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.

I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went back to bed. Up at 6am feeling very fatigued and exhausted. Fever again. Got a shower but couldn't stand up that long too exhausted, dizzy and naseau. Went back to bed and called in sick to work. Took IBU 800mg. Back to sleep. Up at 9m more Tylenol. This continued all day trying to keep fever down. 48hrs later still taking acetaminophen to manage symptoms (back to work) still feeling tried and low grade fever.

Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.

Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.

after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure

Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication . The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21. Information on the lot/batch number has been requested.

Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.

Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.

Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 36 hours. Ibuprofen

I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.

My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.

Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; joint pain (both shoulders, low back, hips, and knee); loss of appetite; fatigue; weakness; headache; muscle pain; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 08Jan2021 on Arm left at single dose (Lot # 3249) for covid-19 immunisation. Medical history included Osteoporosis, vitamin D deficient. No known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. She experienced throbbing pain and tingling fingers in left arm, pain going up the neck of left side. Also experience typical side effects: fever, chills, joint pain (both shoulders, low back, hips, and knee), loss of appetite, fatigue, weakness, headache, and muscle pain on 09Jan2021. No Covid prior vaccination. No covid tested post vaccination. No treatments received. Outcome of the events was recovering.

A few minutes after receiving the vaccine I started feeling very dizzy. I then felt nauseous. In about thirty minutes the dizziness improved but several hours later I still feel residual dizziness and minor problems in GI tract. I slept after returning home, drank water and took Pepcid prescribed to me for my IBS

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Headache and nausea 20 minutes after vaccine given - baseline history of nausea. Resolved after lying supine and a glass of water.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.

1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills, sore throat, nausea 2. Noticed rash on 1/15/21-Rash on right side on stomach, side, and around back

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).

Pt ate lobster risotto for lunch after having the vaccine, approx. 1.5 hours later she became nauseous a began to vomit. Vitals were stable, she was given Pepcid, Benadryl and Zofran before being transported to the ER

Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from a contactable physician (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen and biotin, cyanocobalamin, folic acid (MVI 3). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020 07:15 on the right arm for COVID-19 immunization. On 11Jan2021 21:30 (reported as 'after 12 hours'), the patient experienced severe body aches, chills, headache and temp 100, then after 48 hours (Jan2021) those symptoms resolved, but had GI upset and diarrhea. The patient underwent lab tests and procedures which included body temperature: 100 (no unit reported) on 11Jan2021. The outcome the events severe body aches, chills, headache and temp 100 was recovered on Jan2021 (reported as after 48 hours those symptoms resolved) while GI upset and diarrhea was recovering. The patient did not received any treatment for the reported events.

headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in left arm, on 11Jan2021 00:00 (reported as 12:00AM), at single dose, for COVID-19 immunization, in workplace clinic. There was no medical history. Concomitant medication was not reported. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient is not pregnant. The patient experienced headache, chills, tiredness, nausea and was feeling unwell all on 11Jan2021 14:30. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The outcome of the events was recovering.

36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit

Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).

Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained after other symptoms resolved.

RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.

Headache; fatigue; chills; nausea; vomiting; fever up to 101.4; sweating; This is a spontaneous report from a contactable other hcp. A 40-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported) via an unspecified route of administration on the right arm on 12Jan2021 03:45 at single dose for COVID-19 immunization. Medical history included migraine and acid reflux from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included pantoprazole for acid reflux. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685, expiry date not reported) on 22Dec2020 on the right arm for COVID-19 immunization. The patient experienced headache, fatigue, chills, nausea, vomiting, fever up to 101.4 and sweating on 13Jan2021 12:00. The patient underwent lab tests and procedures which included body temperature: 101.4 on 13Jan2021. The patient recovered from the events on an unspecified date. No treatment was given in response to the events. The patient had no COVID prior to vaccination and has not COVID tested post vaccination.

diarrhea that self resolved 18hrs after injection. diarrhea exactly 7 days from injection that also self resolved.

employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90) 1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified. 1020 Benadryl was given per MD continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired. Assisted to vehicle with husband at 1140

weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.

I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.

Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a nap around 11:30ish felt nauseous, ate to try and calm it but it got worse throughout the day especially at night around 9pm finally relaxed enough to fall asleep, woke up at 7am feeling more nauseous than yesterday with a bad headache located in the front of my head not throbbed but constant. Laying down just felt really sick so I called my doctor around 9:15am.

Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.

severe fatigue 5 hours, moderate headache 5 hours, mild nausea 5 hours and moderate chills for 5 hours

Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.

Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.

12/18 vaccination 9am about 12 Hours later, experienced nausea. 12/19 nausea, body aches, fatigue, severe HA. Took ibuprofren and Tylenol intermittingly. Lasted 8 days. Urgent care on 12/22; Covid test

I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.

after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI

myself the patient i had the first covid Pfizer vaccine on 01/04/21, symptoms started on monday nite 1-04-21 feeling very fatigue and tired, on 01-05-21 felt just a little tired and fatigued had no rash mark, on 01-06-21. i threw up and just a bit tired. After a few days i fully recovered from the first dose of the covid 19 Pfizer, When i received the Second dose of the Pfizer on 01-29-21 that nite i started with a massive headache n chills, on 01-30-31 the entire day had diahrea severe chills massive headache and sweats.On 01-30-21 thru today 02-02-21 i have a round circle rash with heat and bump underneath it each day the rash is bigger were the right arm had the covid Pfizer vaccine injected on 01-29-21.

EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/28/21) due to headache, general body aches and nausea. Came back to work today (1/29/21) and came to EH with c/o uppder body aches, intermittent headaches and a rash to back, chest and bilateral underarms. EE afebrile at this time. EE medicated with Benadryl PO, as per standing order.

angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.

Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline. On 17Jan2021 05:00 AM, the patient experienced nausea and severe headache. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Therapeutic measures were taken as a result of the events which included naproxen and acetaminophen (TYLENOL). Outcome of the events was not recovered.

45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.

A few days after the vaccination I begin having mild symptoms as if I had COVID so I went and got tested on 12/24 and was positive for covid. I was experiencing SOB so I had a virtual Urgent Care and was prescribed a weeks worth of Deckadron and antibiotic and all symptoms cleared up. I also experienced extended abdominal distenstion for an extended period of time.

A few hours after taking the vaccine I began having severe abdominal cramps in my upper to mid-abdomen. It?s been about 48 hours since the vaccine was administered and the abdominal cramps are still present. Also, when I eat food it hurts my stomach. Since this vaccine is so no I wasn?t sure who to contact. I have been waiting to see if the symptoms will subside. If the problem persists, I will seek medical care. I plan to speak with a doctor regarding the matter on Monday.

Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.

felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Lightheaded, headache, body aches, sinuses swollen, nauseous, fatigued, loss of appetite. Felt ill until 24 hours post vaccine, then began to feel better. The following day I felt completely normal.

25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.

inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM: 150/98; RT. ARM: 152/100. has hypertension, has not been taking her BP meds for over 1 month.

hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.

Pain at injection side for a week. Fevers for 2 days up to 103.9. Fever stayed around 102.5 despite taking IBU every 5 hours. Severe fatigue. Then on day 3 had severe nausea.

Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As these were new symptoms and were a week and a half out from the vaccine. Went and was tested for COVID-19 and received a negative test. Missed 3 days of work. No one else in my house hold had any symptoms. No one else in the house hold has been vaccinated.

About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period

Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did

approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow

tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

For me, an egg intolerance resulted within 1 day of receiving the second Pfizer Covid vaccine. I have never had any food allergies or intolerance prior to the date of my (second shot of the Pfizer Covid) vaccine. I?m in the routine of making myself egg and cheese omelets at home each day. Beginning the morning of 1/26/21 (the day after my second Covid vaccine) I ate my omelet as usual and within 2 hours developed stomach cramping, feeling bloated, nausea and severe diarrhea. In the now 4 weeks since getting the vaccine I have never been ill (stomach cramps, bloating, nausea, diarrhea) when refraining from eating eggs. When I do eat eggs now, I simply can not tolerate them, immediately (if I consume the yolk) or within 2 hours (if eating just the egg whites) I will have all the GI issues listed previously. Symptoms typically last for 1-2 hours and are relieved quicker with ibuprofen, I have found.

malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks

Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea

Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.

Excess gas after 2 hours of injection and nausea. 20 hours - lower abdominal pain with feeling of having to use the bathroom

Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.

Patient noted onset of diffuse abdominal pain on 2/25/21. This was accompanied with urgency with loose stools. Subsequently, the patient had persistent vomiting throughout the night. She denies fevers or chills. She has never had similar symptoms in the past. She reports that the abdominal pain localized to the right lower quadrant.

On January 22nd, I began to develop left upper quadrant pain. I was started on Cipro and Flagyl and took that for 7 days. After a couple days I was no better, pain was worse. I underwent a CT scan of abd/pelvis and was found to have Colitis. I have no history of this. I still was not improving so I was started on steroids (prednisone). Pain improved somewhat, but did not resolve. I then underwent a colonoscopy that demonstrated active and focal colitis in multiple areas of my colon. Again, I have no history of this. I spoke with my PCP who recommended that I not take the second dose, and report this to CDC as a possible hyper immune response.

Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.

arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.

Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.

Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm

chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.

post vaccine - c/o sharp pain in head Tues and now "feels like crmps in head" and still had pain in LA radiates to back. denies hx of heart disease or HTN, denies DM, "low white cells per family hx". CG excluded, declined to be tested or MD eval. Advised G to f/u with MDfor symptoms and eval, and to F/U with CL regarding pay

After 1st dose, had some hearing loss due to fullness in ears, took 2 weeks for symptoms to subside. Since 1st dose, have had 4 HSV1 cold sores come about. After 2nd dose experiencing severe heartburn. Also continue to have HSV1 cold sore outbreaks.

Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.

At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.

Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks, facial rash/flushing daily the past week 2 weeks from last dose. Severe fatigue unable to do my daily activities, missed work and sought care by pcp. Trying to see immunology at where vaccine was administered and Getting the run around by everyone.

Patient stated, "It feels different when I swallow." Patient stated the feeling started 5 minutes after getting the vaccine. t 12:59 pm patient stated she is feeling ok and wants to go home. She is swallowing fine.

Pt. stated, "It feels different when I swallow." Patient stated the feeling started 5 minutes after getting the vaccine. At 12:59 pm patient stated she is feeling ok and wants to go home. She is swallowing fine.

Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.

Near syncope (multiple events); vomiting (multiple events); chills; headache Onset approx. 12 hours following vaccine. Rapid onset with little to no warning, lasting approx. 2-3 hours.

Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrine IM, sent to ED for eval

Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.

Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE). The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Information on the lot/batch number has been requested.

Severe chills began about 7.5 hours after vaccine. Followed by headache, body aches, fever, fatigue and nausea. Took both Tylenol & Motrin. Chills came in waves for 24 hours. Fever got up to 101.8 roughly 12 hrs after vaccine. 48 hours after vaccine still have headache and fatigue.

chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100. Fatigued, so went to bed and took ibuprofen. Continued to have significant body aches and rigors. While lying in bed, developed nausea. I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode. I returned to bed bed and still felt very lightheaded and laid down. I had another brief syncopal episode while lying down. I felt short of breath and had chest tightness when I woke up. This was around 11pm. I was evaluated in the ED, where I continued to have body aches and rigors. I developed fever to 101 and was given Advil and Tylenol as well as IVF. Symptoms finally resolved. Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal. Continued to feel significantly fatigued for an additional 48 hours.

Headache since about 15 minutes after injection. Injection site pain started about 10 minutes after injection and stopped after day 2. Tiredness started a few hours after injection and got better after day 4. Muscle pain and chills started the same day and stopped on day 4. Injection site swelling started on day 2 and went down on day 4. Injection site redness started as pink but is now purple. Nausea started within 10 minutes of injection but went away the same day. Feeling unwell started the same day of the injection and has been ongoing off and on since. My whole arm felt swollen on Saturday. The same day, I started noticing blood blisters on my fingertips on my left hand. More and more have shown up since then.

Patient received first dose on 9 March 2021 at approximately 1430. Patient started to experience facial tingling, right arm tingling, shortly after approximately around 1430. 1445 tingling remained, member also started to complain of difficulty swallowing. Patient assessed by medical provider. Vitals and patient history obtained from patient. Member transported to TAMC at 1513.

The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively. The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.

Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm. The following day my body hurt, headache, mild nausea. Still have pain in lymph node under vaccinated arm and arm muscle twitch. Mild dehydration.

Headache ~ moderate Nausea ~ mild Fatigue/tiredness ~ moderate *Nothing severe ~ just reporting side effects of first vaccine dose*

a couple minutes after receiving the vaccine the patient reported nausea. was directed to have a seat, provided with a bag in case of vomitting (not needed) and a bottle of water. a few minutes later she was feeling better. had patient remain at pharmacy for 30 minutes post vaccination. and she continued to be fine.

Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.

Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue

Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.

The patient did not have a direct adverse event from the Pfizer vaccine. This report is being submitted as a result of testing positive for COVID-19 after being fully vaccinated for COVID-19. The patient had previously tested positive for COVID-19 on 11/28/20 and fully recovered. The patient then received her second Pfizer vaccine on 1/21/21 with no reactions or adverse events. On 3/7/21 the patient reported symptoms consistent with COVID-19 and was then tested for COVID-19 on 3/13/21. Her antigen test was negative and PCR test was positive. At the time of her test she was having the following symptoms: subjective fever, chills, myalgia, headache, runny nose, nasal congestion, cough, nausea, and diarrhea. She was also tested for influenza on 3/13/21 with a negative result. A report was filed per regular protocol. Nurse also notified department of the case and provided further information for investigation. Patient reported that she had recently flown back, but had not knowingly been exposed to any ill individuals.

a female patient at the hospital with appendicitis; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , batch/lot and expiry unknown), via an unspecified route of administration on 22Feb2021 at a single dose for covid prevention. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of Covid vaccine on 03Feb2021 (40 years) for Covid-19 immunisation. 4 days after getting her second dose of the Pfizer COVID Vaccine, patient was in the hospital with appendicitis on 26Feb2021. Patient was hospitalized, and he believes the patient was heading into the operating room (OR) now. It was confirmed that the patient had no other vaccines on the same day as both her COVID vaccine doses. The causality was reported as "unrelated". Information on the Lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considers that the event appendicitis is unrelated to suspect vaccine BNT162B2. Appendicitis is most likely an intercurrent condition. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile.

Approx 12 hours after second dosage of Pfizer Covid vaccine, I became nauseous and had chills. Then diarrehea began. Next, vomiting and diarrehea began (at the same time).

I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it. The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever. Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well. it has been relieved with Benadryl nightly.

severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received. Information on about lot/batch number has been requested.

Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling all around unwell. I was so tired in the middle of the night I did not wake up when I was coughing and could not breath and was gasping for air. Because i was so fatigued I almost suffocated.

Fever 99-105 Muscle Aches Headache Fatigue Nausea Lasted 24 hours. Fever responded somewhat to aspirin.

The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination. She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination. She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing. She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine. May be allergic or due to complement release. Treatment course - took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up

Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.

10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)

On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.

1/7 vaccination 1/10 I woke up at 4-5 am, incredibly nauseous. I had diarrhea, thought i was going to vomit. Felt very ill. I couldn't work as I felt so ill even for zoom meeting. Symptoms were off and on for 2 weeks. 2 weeks after I went to see PCM. Couple days later, relapse into severe nausea, diarrhea. Went to telehealth, went to ER. Blood panel; ok. It seemed very coincidental.

03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid

Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a syncopal episode where pt was seen with flexed arms and bladder incontinence. Pt was AOx4 after regaining consciousness with SBP in the 80s, diaphoresis, and nausea. Pt did report history of syncopal events associated with needles and SBP around 90s. Pt was monitored and later released by medical staff and EMS after symptoms resolved. PT was instructed to follow up with PCM regarding possible concerns for seizures and hypotension.

Swelling/soreness at injection site. Diarrhea beginning the morning after injection and lasting into the evening. Treated with over-the-counter medications (Ibuprofen and Imodium)

Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.

dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and effort to speak a singular word or move any part of body; nausea; vomitting; Hands/ fingers, legs, eye, all developed tics; Legs were twitching all night; little achey; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 16:30 PM (at the age of 40 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), gabapentin, fluvoxamine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexine and experienced drug hypersensitivity. On 06Feb2021 at 17:30 PM, the patient started to get dizzy, feeling "drugged", numbness, then loss of most use in hands (significant weakness- could not hold a cup), took extreme amount of planning and effort to speak a singular word or move any part of body, nausea, vomiting, hands/ fingers, legs, eye, all developed tics, legs were twitching all night, little achy. No treatment was taken for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 18Feb2021, Nasal Swab: Negative. Information on the lot/batch number has been requested.

Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatment: 500 mg Tylenol x1 dose. After second immunization experienced severe chills with uncontrollable shivering/shaking and then profuse sweating and hot sweats for approximately 4 hours. Nausea followed the next morning along with an approximately 36-hour headache. Rested x2 days in bed. Treatment: Ibuprofen 800 mg alternating with acetaminophen 500 mg without relief x multiple doses.

Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the legs. Bladder and bowel problems - urinating frequently, urinary incontinence and constipation.

My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.

Patient reports nausea and dizziness following vaccinations. Patient states she was feeling anxious . Took patient vitals to find them stable. Patient states her symptoms had recovered and refused transport to ED.

Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram

Moderate Diarrhea lasting ~4 hours, mild nausea, 102.7 fever, mild headache, sever joint & muscle pain, sever foot pain in sides of feet, severe sensitivity to touch, all beginning~11:00pm day of injection and subsiding ~24 hours later. With mild to Moderate joint pain persisting for an additional 24 hours. Moderate head pressure and Moderate dizziness starting upon waking up 3/27/2021, requiring setting medical attention with medication being prescribed, and symptoms have not eased at this time.

Constipation, chills, intestinal/stomach cramping, many liquid bowel movements, fever, extreme fatigue & lethargy, body/joint aches, mental fogginess, headache, all lasting one day. Liquid bowel movements, intestinal cramping lasting into day 2.

On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous

The morning after I got injection #2, I woke up and had to run to the bathroom to throw up violently. I broke blood vessels in my face. Since then, I've thrown up 2 other mornings, including today, and have been so nauseous part of each day.

Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.

I went to emergency room due to abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 19:00 (lot number: PAA156051) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient went to emergency room due to abdominal pain on an unspecified date. No treatment was given for the event. Prior to vaccination, the patient had no COVID and patient was not tested for COVID post-vaccination. The patient was not pregnant at the time of report. The outcome of the event was unknown.

sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.

1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on health check-in. Muscle spasms, diarrhea, could not keep down water, HA, fatigue, lethargic. I thought I was dying. 1/21 0400am ER 1/22 ER 1/23 ER 1/24 ER; admitted inpatient to hospital. 11 Days inpatient. Nausea, vomiting, diarrhea, feverish, malaise, gastric spasms, HA, *12/2020 Gastrectomy *Symptoms lasted whole duration in hospital. Could not keep any liquids down.

dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)

had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration

About 2-5 minutes after shot, I couldn?t swallow. My throat muscles just wouldn?t work, but it was really sporadic like once or twice every 30 seconds-2 minutes I was not able to swallow. After 30 minutes of no worsening and waiting at vaccine site, my throat became itchy on my drive home and i had to clear it often. Rarely this happens to me if I eat honeydew melon or drink soymilk. I went to Urgent Care, throat looked open and they told me to take Benadryl. I?m curious if you?ve had reports like this of sporadic throat inoperation and if it will happen worse with the second dose.

At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.

Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migraine headache; vertigo; weakness; They obtained an FSH level and it had skyrocketed from previous values not long before; my ovaries had shrunk in size by approximately half; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), first dose via intramuscular, administered in right arm on 19Dec2020 09:30 at a single dose (lot number and expiry date were not reported); and then received the second dose on 02Jan2021 09:30 (lot number and expiry date not reported), intramuscularly administered in right arm as a single dose; for COVID-19 immunisation. Medical history included eosinophilic esophagitis and asthma. The patient had no known allergies. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications which were taken in two weeks prior to vaccination included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, norethisterone acetate (LOESTRIN), taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 19Dec2020, the patient experienced diminished ovarian reserve. Patient stated that she was extremely symptomatic after both vaccines and starting on 19Dec2020 had experienced fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness. The hot flashes persisted and worsened after each subsequent vaccine, prompting her to go to my MD. They obtained an FSH level on 19Dec2020 and it had skyrocketed from previous values (dates unspecified; unknown results) not long before. An ultrasound on 19Dec2020, showed that her ovaries had shrunk in size by approximately half and she had diminished reserve. Patient was now on supplemental hormones and will be for many years to come as she was only 40. Patient know the vaccine caused this. It was too great of a coincidence. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a result of the events reported patient was now on hormonal replacement therapy. The patient was tested for covid post vaccination which included nasal swab/Covid test on 14Mar2021 as negative. The outcome of the events reported was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded, for events fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness, conversely the suspect drug is considered very unlikely related for other gynecological disturbances. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.

Severe GI cramping; diarrhea; nausea; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 12:15 (Batch/Lot Number: EN6201) (at the age of 40-years-old) as single dose for covid-19 immunisation. The patient medical history included none. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Right on 20Jan2021 11:00 (Batch/Lot Number: EL-9261) (at the age of 40-years-old) for covid-19 immunisation. On 12Feb2021 03:00, the patient experienced severe GI cramping, diarrhea and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events included 2 litres of fluids, IV, IM and po medications. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and know drug profile a contributory role of BNT162B2 to the reported severe GI cramping, diarrhea and nausea cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

diverticulitis; perforated colon; it caused an abdominal infection and inflammation; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better; This is a spontaneous report from a contactable consumer (pateint) via a Pfizer-sponsored program COVAX Support. A 40-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17Mar2021 10:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient and concomitant medications were not reported. The patient experienced diverticulitis, perforated colon, abdominal infection and inflammation on 30Mar2021; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better on an unspecified date. The patient was hospitalized for diverticulitis, perforated colon, abdominal infection and inflammation from 30Mar2021 to 01Apr2021. The all events were resulted in Emergency Room and Physician Office. Patient was due for second dose of Pfizer BioNTech Covid vaccine tomorrow (08Apr2021) but was hopitalized last week for diverticulitis and a perforated colon. She was released from the hospital last Thursday and is currently taking Metronidazole 500mg three times a day and ciprofloxacin 500mg1 tablet by mouth every 12 hours. At her follow up today (07Apr2021) the doctor was unsure of a recommendation. She lost her vaccination card. She mentioned that she will be having the 2nd dose tomorrow 08Apr2021 and she wants to know if possible since she doesn't have the card. She mentioned that she got hospitalized last week and she is under medication due to abdominal infection and she is taking antibiotics until next 2 weeks. She was in the hospital for diverticulitis and a perforated colon two nights last week and was pumped with a ton of antibiotics and is currently on antibiotics. It caused an abdominal infection and inflammation and she received five bags of antibiotics and was sent home with two different antibiotics, one for 2 weeks and one for 3 weeks. She is essentially from tomorrow to two weeks on antibiotics and didn't know if it would be an issue with getting the vaccine. She asked her family physician and he said he would probably wait because there is a chance it would counteract with the vaccine. Caller states her daughter lost her vaccination card and asks if this is going to be an issue as long as she goes to the same place she went to get her second shot, states this must have happened to other people. During that time at the hospital she had a total of five bags of antibiotics. She was still having a little bit of pain in her abdomen and probably why she was on antibiotics for two weeks. She was in a lot of pain but is mostly better. About the treatment, patient stated she was on morphine while in the hospital and they did a CT scan with dye. Patient stated all her blood work came back healthy. The outcome of the event abdominal pain was recovering, other events was unknown. Information on the lot/batch number has been requested.

lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.

1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.

runny nose; felt sick; colds; GI symptoms; tired/fatigued.; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021; sars-cov-2 test: positive on 15Feb2021/formally tested positive on 22Feb2021; This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse reporting for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number E13302/expiration date: not provided), via an unspecified route of administration, on 01Feb2021 at 15:00 as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included smoker. Concomitant medication included varenicline tartrate (CHANTIX) from 25Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced runny nose, felt sick, colds, GI symptoms, and tired/fatigued. On 15Feb2021, she took a home sars-cov-2 test and tested positive. On 22Feb2021, the patient formally tested positive. The events did not require an emergency room or physician's office visit. Treatment received for the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19 included Dayquil and she was on steroids for cold. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive on 15Feb2021, sars-cov-2 test: negative on 15Feb2021, sars-cov-2 test: positive on 22Feb2021, sars-cov-2 test: positive on an unknown date, sars-cov-2 test: negative on an unknown date. The outcome of the events runny nose, felt sick, colds, GI symptoms, tired/fatigued, and tested positive for COVID-19. was unknown. The reporting nurse assessed the event "sars-cov-2 test: positive" was unrelated to BNT162B2 (COVID vaccine).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.

acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a spontaneous report from a contactable consumer (the patient). This 40-year-old (non-pregnant) female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had tested negative for COVID-19 with the Nasal Swab Real-time PCR tests on 17Oct2020 and again on 02Feb2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did have an allergy to eggs and having no other medical history. The patient stated that she is completely healthy. The patient's concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination. On 02Apr2021 at 10:00 AM, the patient experienced strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever. No treatment was received for the adverse events. The patient had a low blood pressure measured 80/50 mmHg on 02Apr2021. The clinical outcomes of the strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever were resolved in Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Pancreatitis flare-up began as the side effects intensified/ Felt like pancreatic and GI inflammation; Pancreatitis flare-up began as the side effects intensified; Felt like pancreatic and GI inflammation; Could't keep any food or liquid down; vomited green stomach bile; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 AM (Batch/Lot Number: ER8734) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 40 years old. Patient was not pregnant. Medical history included Chronic Pancreatitis (idiopathic) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Occassional Benadryl allergy and Tylenol, both taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and experienced known allergies, bnt162b2 for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (brand=Pfizer; lot number=EW0172) on Apr2021 03:45 PM at Left arm for covid-19 immunization. The patient experienced pancreatitis flare-up began as the side effects intensified (medically significant), felt like pancreatic inflammation (medically significant), GI inflammation (non-serious), could't keep any food or liquid down (non-serious), vomited green stomach bile (non-serious), all on 25Apr2021 18:00 with outcome of recovering. Reported as pancreatitis flare-up began as the side effects intensified. Could't keep any food or liquid down and vomited green stomach bile. Felt like pancreatic and GI inflammation as my immune system responded to vax. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected

Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.

Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.

12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.

Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.

Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen

On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.

episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one is the patient). A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 at 12:45 at a single dose for immunization. Medical history included benign paroxysmal positional vertigo, but the patient has not had a flare of this condition in 3.5 years. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient who has a history of Benign Paroxysmal Positional Vertigo (BPPV) had not had a flare of this condition in 3.5 years. Previously, it has only been brought on by scuba diving, then she woke up the day after receiving the Pfizer COVID 19 vaccine, on 23Dec2020 at 06:30 with an episode of vertigo consistent with prior episodes of BPPV. She has associated nausea and vomiting, and her symptoms mostly resolve with doing home exercises, rest and time. On 29Dec2020, that is day 7 after the vaccine and she still have mild vertigo. She has no fevers, chills, or myalgias. She stated that perhaps it was a coincidence but thought it might be worth reporting, and she fully intend to get the second Pfizer vaccine when available. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications were received by the patient within 2 weeks of vaccination. The events nausea and vomiting resolved in 2020 while the rest of the events was resolving.

nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient herself). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the right arm on 21Dec2020 at 07:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included asthma. The patient had no known allergies; no allergies to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 at 06:00, the patient experienced nausea, diarrhea, and upset stomach, which were assessed as non-serious. The patient did not receive treatment for the adverse events. The patient was recovering from the events "nausea, diarrhea, and upset stomach."

very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.

mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic response; This is a spontaneous report from a contactable physician. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 23Dec2020 12:30 at single dose for COVID-19 immunisation. Medical history included allergies to medications, food, or other products: Penicillin. There were no concomitant medications. The patient previously took benzoyl peroxide and experienced allergies. The patient experienced stated that on 23Dec2020 12:31, "I am an ENT surgeon. I received the first dose of the vaccine at 12:30pm. Within 1-2 minutes I started to feel difficulty swallowing (globus). I reported this to the nurse and she offered me ginger ale. My symptoms worsened and then stabilized after 10 minutes. I went upstairs and got the residents to perform a fiberoptic nasoendoscopy and this demonstrated mild supraglottic swelling of my aryepiglottic folds. I choose not to receive treatment as I did not want to dampen my allergic response and as an ENT surgeon manage airways on a daily basis. I stayed at the hospital for a further 6 hours and continued to work. My symptoms resolved after 9 hours". The outcome of the events was recovered on 23Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event laryngeal oedema cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl

Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain

Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.

site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl

woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.

Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.

Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination. The outcome of the events was recovering. No treatment was given for the events. No follow-up attempts are possible, information about batch number cannot be obtained.

NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.

Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.

Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.

Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue

chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.

felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient) A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.

Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released

Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.

I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.

Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.

Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.

12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in external genitalia, Had ulcerations with bruising on 1/9/21. (Lesions)

Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.

Rectal bleeding; Stomach ache; Diarrhea; sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A 41-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right arm on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 01Jan2021, the patient experienced: rectal bleeding, stomachache, diarrhea, sick; all assessed as medically significant. The clinical course was reported as follows: The patient received the first dose of the COVID-19 vaccine on 20Dec2020; as she was at high risk due to working with COVID patients in the hospital. The patient became sick on 01Jan2021. The patient experienced a stomach-ache, diarrhea, and rectal bleeding. When these events occurred, the patient went to the emergency room (ER). A doctor there prescribed the patient the antibiotics metronidazole 500 mg and cefdinir 300 mg. The patient was also scheduled to follow up with a gastrointestinal (GI) doctor. The patient called asking if she should get the second dose since she was taking antibiotics. The patient was scheduled for the second dose on 08Jan2020.The patient reported she had improved. The symptoms, at the time of the report, were not that bad. Therapeutic measures were taken as a result of rectal bleeding, stomachache, diarrhea, and sick. The clinical outcome of the events was recovering.

palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing

Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.

Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.

a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.

Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.

Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.

So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.

01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.

10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.

Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.

Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has remained for over 24hours.

I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.

Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.

Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.

not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient). This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.

within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.

Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.

Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)

I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration from 07Jan2021 10:00 at left arm, at single dose for covid-19 immunization. Medical history included COVID 19 positive 12Dec2020, the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was reported no. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient received vaccine at 07Han2021 10:00PM (as reported). 4 hours after receiving the vaccine 07Jan2021 14:00 the patient vomited several times, the patient had and still have severe headache, muscle aches, chills, joint pain, tiredness and fever. The patient realized that these are side effects and not adverse reactions but she felt that they were quite severe and she thought it was due to the fact that she so recently had COVID 19. OTC meds were received for all events. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.

Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.

On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.

Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.

Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.

COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.

Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue

I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.

I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.

severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from a contactable physician (reported for herself). A 41-year-old female patient (Pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3248), via an unspecified route of administration on 10Jan2021 08:30 at single dose for COVID-19 immunization. The patient's medical history included Allergies to amoxicillin. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (lot number: ek9231) on 22Dec2020 21:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills, severe nausea (no vomiting), neck aches, headache on 10Jan2021 20:30. Treatment received for the adverse events included tylenol 1g x3 doses. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Jan2021.

Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.

On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.

at 6:00 pm I had diarrhea and the pain in my left arm started and I tooke tylenos 350mlg. I had a headache in the middle of the night. today i woke up with a lot of pain non my left arm and shoulder and iI put Cbd pain cream all over my arm and tooke paracetamol 650 mlg for pain.

Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work

I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting and diarrhea.

Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out

general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.

Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm

About 17 hours after receiving the vaccination, I had vertigo. I woke up at 4:30 AM half an hour before my usual wake-up time, and the room was spinning and I had a headache. I had nausea at the time. I was unsteady for about 30-60 minutes, until I took Dramamine, which resolved the issue that day. Then about 24 hours after I received the vaccination, I developed chills and fatigue ( I didn't check by temp). I have been having vertigo daily and a headache upon waking up in the morning (today is 5 days post vaccination), and today, this was associated with an episode of emesis without nausea or abdominal pain. I did not have these issues previously.

Nausea, vomiting, and body aches within 3 hrs of injection. Swelling and pain at injection site. Cellulitis at injection site, L armpit, L breast, lymph nodes, L shoulder. Prescribed antibiotics and instructed to take OTC NSAIDS and Anti-hystamimes. If symptoms don't abade seek further treatment, possibly IV antibiotics.

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

Status post vaccine #2 Pfizer covid vaccine. R arm r preast started itching approx 7:45 . 8:16 Took own allegra, increased pruritis 8:40 called 9111 employee taken to clinic treated with benadryl and zyrtec, MD next day told to take allegra and Pepcid. 1/14 employee returned to work. Started Diarrhea on 1/15. Had intermittent diarrhea since then, still has pruritis. all over. Taking allegra and pepcid. benadryl at night. Employee Advised to contact allergist for appointment. Advised to contact MD again because of the persistent itching.

This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.

body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm

following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.

Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.

Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.

Two days after my second COVID vaccine I felt pretty bloated although my fatigue/chills/aches from the previous day had subsided. That night I got hives on my neck, shoulders, chest, breasts and upper abdomen. They were not itchy and went away without treatment that night but I got up in the night to go to bathroom and had small amount of blood from rectum. The blood from rectum and bloating has continued. It is only a small amount of bright red blood but has occurred about 5 times since that second dose of vaccine.

Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion

seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite

All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.

symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not sleeping well treatment: resting, sleeping, acetaminophen, drinking fluids all symptoms started approximately 24 hours after the shot was administered. symptoms have not resolved as of typing this at 2117 28January 2021

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.

It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.

Saturday morning. Whole body aches and chills. Severe headache all day. Nausea and eventually vomiting twice in the evening. Very exhausted. Tried tylenol, cold packs, hot packs, ginger ale - none were helpful. Took long hot shower and bath after vomiting and felt a little relief. These symptoms lasted 12 hours or so and then I felt fine besides being exhausted. By Sunday evening I was completely back to normal.

This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.

Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased

Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.

Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Starting the day after the injection she began having a fever as high as 102.4, severe chills, joint pain, headache, nausea, vomiting, body aches

Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.

have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.

Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.

This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.

high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.

12 hour post vaccine severe muscle joint pain, headache , nausea with vomiting, extreme Fatigue and muscle weakness.

12/18 vaccination 12/19 Nausea started in afternoon. Fever off and on; comes and goes. Nausea, vomiting has consistently been present till present date. PCP,video chat; blood work and possible nausea meds is scheduled for 2/8/2021. *it is not all the time, it comes and goes. Some days better then others. I had to leave work on 4 occasions.

Around 6pm on Monday night (the day of my injection) I was feeling nauseous, I couldn't eat dinner, then around 8:30 i started vomiting this continued until around 1am (i vomited around 4 times). I also had chills and body aches through the night. Tuesday I felt exhausted and had horrible body aches. Around 3pm the body aches were mostly gone but i still had no energy for the rest of the day. Today, Wednesday, i'm a little achy and still lack energy but feel much better than yesterday.

Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours. Headache, lethargic, achy, slight fever, very sore arm and shoulder/neck.

Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.

Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.

Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , headache, Took Advil and headache was worse.. The following day I still had a really bad headache and felt nauseated .

Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still remains at site of injection Pain on top of head, but not necessarily a fullbown headache

pt states that she started running fever 99.8 with chills, headache, body aches, vomiting and diarrhea later on the day of the vax. Next day she only had body aches. She stated that today 2/5/2021 she has body aches, headache and dizziness. Pt has not contacted her PCP at this time.

After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.

Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea

Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

Around 11 hours after 2nd shot I woke up with chills, full body tingling, nausea, and couldn't get comfortable. About 5.5 hours later I had spiked a fever (101.1 temporal) and bad headache. The fever and headache continued all day. Around 7pm on 2/3 I took 1 extra strength Tylenol. The fever broke by Thursday morning and I was feeling better though I still had a headache. I did take 1 extra strength Tylenol around the clock Thurs into Friday. The headache continued to improve Thursday and finally went away by Saturday evening.

got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine caused nausea and vomiting, then started with body aches, fatigue , it's been 5 days now still have migraine.

About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation. It was like the roots of all the molars were irritated. The nerve sensation also felt like it was in the upper jaw/face area. My entire pallet became irritated. This lasted for about two hours and then went away completely.

Extreme fatigue, body aches, dizziness, light nausea (starting an hour after and lasting still, 52 hours later),

c/o headache and nausea within 5 minutes of getting the vaccination. Has a history of migraines but migraine was sudden onset. Pt monitored in my office states she had history of migraines and uses Imitrex. She refused to go to ER and injected her imitrex and was monitored for an hour . Again refused to go to Er called her mother in law to take her home. 1700 called her states still had minor migraine but somewhat better at this time.

Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19

Woke up extremely dizzy and this lasted the entire day and was only able to get up at 6:30 at night. Patient was extremely nauseous the whole day as well and when she moved she vomited. Episode progressed slightly into the next day but symptoms improved and resolved. Took Tylenol and Dramamine.

Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.

Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)

Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.

On 1/12/2021 around 2 am I started feeling, chills, body aches, headaches, diarrhea & fatigue. They lasted 50 48-72 hours. I took Tylenol for my symptoms. I did have Covid-19 on May 2020.

Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.

About 16 hours after shot some soreness/pain up my spine, still could do daily activities- took some ibuprofen as needed. But after 24 hours abdominal pain, still able to do daily activities but during that evening's sleep the pain went up and felt like the early stages of labor through till the morning-- then I took ibuprofen. This abdominal cramping was steady in the night and did not easy for many hours and caused me to vomit. Due to pain and vomiting I was not able to go in to work for the day but was able to recover by lunch time with ibuprofen and rest and so I could return to work the following day.

Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.

Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today on 3/1/21 continues to have headache every morning but not as severe and today has had 3 loose, watery stools.

MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

The arm pit got swollen up and the whole left side of the body started aching really badly. Could not move around and got headache and nausia too. That is still continuing tiil date.

pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.

Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm

Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.

About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.

Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.

Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM

Fever 101-102 (36 hours) Extreme exhaustion- unable to raise head from pillow or get up or do anything Chills/shivering Got the shot Saturday. Woke up Monday fine, sat on couch to check on kids/schoolwork, very suddenly felt a wave of fatigue, laid down and was unable to rise for the next 12 hours. Then got up with help, got to bed and slept until midday Tuesday. Then Tuesday started diarrhea lasting about a week. Cough started Tuesday night, lasted a few days. Doctor was concerned for actual covid infection (no known exposure) so got tested- was negative.

Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by medic on site.

1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist

At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.

Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she developed itchiness, nausea and difficulty swallowing 1 hr after the administration on the Pfizer vaccine. Pt stated that she still has some difficulty swallowing but all other symptoms have resolved. Pt denies having chest pain, sob, throat itching, throat tightness or feeling of suffocation. Pt stated that she begin having hoarseness begin this morning which new onset. Patient sought care in ED room 3/1 and 3/4, follow-up visits with PCP and allergists. Unable to work.

Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light headed. Took benadryl po 50 mg. Was seen at ER. Received albuterol neb, steroids IV, and prevacid PO. Sent home with po steroids and benadryl. S/S improved after treatment.

o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.

o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.

Fever, lethargy, joint pain, headache, nausea, vomiting, diarrhea for 3 days. The worst was the joint and skin pain.

Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.

6 days after second vaccine hives over body. Prednisone five day course given beginning February. Hives resolved for one week, returned one week later inclusive of abd pain. Hives and or abd pain continue almost daily. Rheum labs negative basic panel normal. Allergist appt scheduled

Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.

Patient complained of nausea and lightheadedness about 15 minutes after receiving the vaccine. She denied itching, hives, swelling of tongue or throat. Did not feel faint. Approximately 30-40 minutes later she had improvement of nausea and lightheadedness but felt some swelling on left side of throat. Physical exam still WNL. She declined paramedics. She wanted to leave and was felt to be stable. Did not become syncopal on standing. She is "7 belted mixed martial artist." Planned to return home and possibly take Benadryl. Left at approximately 3:50pm

Patient developed generalized puritis, nausea, hives to left triceps. Patient stated she is prone to allergic reactions to other medication therapies.

1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.

Chills, Fever, (my normal temp is 97.4-97.8 daily for the past year) and after the shot, my temp rose to 99, 100, 101.2 - from Sat., 3/6 - Sun., 3/7. I was exhausted and slept most of the night and day on Sun., 3/7. I then woke up thinking the worst was behind me - I ended up getting stomach pains and had diarrhea late Sun., 3/7 and into Mon., 3/8 followed by a throbbing headache and feeling super tired. The headache lasted through Thursday afternoon and is gone now. I am still pretty tired.

In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness/fatigue Headache Muscle pain Chills Fever Nausea Armpit pain Lymph nodes swelling (size of an egg) discomfort with arm movements Itchiness Lack of appetite Pain in shoulder blade

It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach ach, night sweating, sleepless, shoulder ach

Pfizer-biontech COVID-19 Fever Nausea Fatigue Muscle ache Diarrhea Dizziness feeling unwell Headache Took Tylenol every 6 hours. Drank lots of water. Got lots of rest. Symptoms persisted for about 12-18 hours. Diarrhea and fatigue persisted for 1 week.

- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness and disequilibrium that were accompanied with mild nausea. The numbness in teeth went away after approximately 5 min. The waves of disequilibrium continued for 24hrs, and now feel more like a pressure headache. During these ?waves? I also had increased heart rate. - an hour after the shot, my left arm felt numb down to the fingers. Then the right arm and upper back. This subsided after an hour.

sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mouth and tongue started to get itchy - went to see nurse : took 50mg Benadryl 40 minutes after vaccine shot: difficulty swallowing: need to clear throat 50 minutes after vaccine shot: nurse suggested taking my EpiPen but I was still able to breathe (all other symptoms were still very present Approximately 25-30 minutes after taking Benadryl symptoms began to subside. No EpiPen was administered. Approximately 95 minutes after vaccine shot: symptoms were reduced enough to go home.

Appox. 15 minutes after receiving 2nd dose of Pfizer Covid vaccine patient stated she has slight nausea and light headedness. BP 133/88. Patient states her sugar levels are low and needs something to eat, asked patient to wait another 15 minutes before leaving. Patient ate a piece of fruit and stated she felt better. She also stated this happens because of her Diabetes and she did not eat breakfast.

Client was in the monitoring room after receiving first dose. Reported to the nurse felt like throat was swelling and having difficulty breathing and swallowing. Nurse reported client was visibly having a hard time with breathing. Client reported felt weak and legs felt "like noodles." Epi Pen given Left thigh. 911 called . Client accepted transport for further evaluation.

Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injection.

About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription

Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes, body aches. Felt better by 6 AM Saturday except sleepiness and body aches. Sleepiness/achiness stopped around 4:30 PM Saturday. Injection site sore from shot until Sunday evening.

Heartburn starting at 48hr post vaccination; Headache; chills; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Feb2021 08:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation at a workplace clinic. Medical history included allergies to sulfur drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included probiotics, vitamin d [vitamin d NOS] and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3247) on 28Jan2021 08:00 in the left arm for COVID-19 immunization. The patient experienced heartburn starting at 48hr post vaccination, headache and chills on 20Feb2021 08:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of heartburn starting at 48hr post vaccination which included heartburn medicine. The outcome of the events was not recovered.

1) Ongoing headache - going on 6 days (similar symptoms when I had COVID) 2) GI symptoms - diarrhea, loss of appetite, nausea - also on-going since day after receiving vaccine

Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.

24 hours later, I developed issues with my throat. I have spasms that feel like my throat is tightening up. This has been going on for 3 weeks. I have trouble swallowing and i constandly feel like something is stuck in my throat.

3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'. A/O, W/D, RESP REG WITH EASE. NO DIFFICULTY SWALLOWING. NO ACUTE/OBVIOUS DISTRESS. 7:15 AMBU TO BATHROOM. 7:26PM STATES SHE 'FEELS BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. RESP REG WITH EASE. NO DISTRESS NOTED. 3-25-21 8:15 TC: PT STATES SHE IS 'ALL BETTER TODAY'.

At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water. Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA. Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.

Per Client received first Pfizer COVID 19 vaccine on 2/23/2021 in left arm, slight redness and tenderness at site. Received second Pfizer COVID 19 vaccine on 3/24/2021 in left arm and old site became symptomatic not new site: Hot, red, swollen, painful, hard to touch two inches across site. Next day on 3/25/2021, chills, fever of 102, nausea, vomiting x 2, fatigue and sore left arm pit. Client reported taking Ibuprofen, applying cold and warm compresses to site and no follow up with PCP as of yet. Client reported still having symptoms and will plan to follow up with PCP if still having concerns on tomorrow. PHN encouraged Client to continue monitoring site and to follow up with PCP.

This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76

2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.

Started with stomach pain and generally not feeling well. I thought maybe it was indigestion from lunch and took pesto bismol. About 20 min later, stomach felt worse amd i vomited. Stomach did not feel better. Started to get severe stomach cramping that got worse and got chills. Took my temperature when the stomach cramps let me move, but temp was 97.9. So just wrapped up in a blanket. Cramps amd chills subsided about 6 oclock. Was able to eat a light dinner about 6:30.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

Developed abdominal pain 4/7. Diagnosed with acute appendicitis 4/9 and underwent laparoscopic appendectomy 4/9. Also incidentally noted to have complex cystic pancreatic tail mass up to 8.3 cm with 7mm and 4mm RLL subsolid lung nodules. Patient has been discharged after appendectomy, and further workup of the pancreatic mass is planned. The appendicitis AE is resolved, but the pancreatic mass and lung nodules (likely not related to vaccine) are ongoing at this time.

Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given

- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS

Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.

asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst physical pain in lifetime

Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.

arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.

migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.

Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.

pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.

Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.

Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.

About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.

About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.

Employee received the COVID vaccine on 12/23. She developed abdominal pain on 12/29. Was seen in the ED on 12/30 for an emergency appendectomy. Employee states that the CDC website lists appendectomy as the most common severe adverse event in the COVID vaccine group. Which was numerically higher than in the placebo group.

Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.

arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision

itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.

she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.

Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.

Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique

I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.

3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.

After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.

Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.

When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed through and worked the whole shift. I was off due to the holidays for some days but symptoms did not improve. I had the vertigo and nausea for 11 days and on day 7 it prompted me to seek medical care at the clinic. The headache lasted only 2 days.

When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor. I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days. I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away. They run bloodwork all normal. They told me to take OTC meclizine. It took the edge off helped a tiny bit. I woke up 01/01 symptom free.

immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her "tired and achey". She was referred to her PCP for follow up>

2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.

The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks

-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol

Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and difficulty swallowing. Patient presented to emergency department.

After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20

Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.

The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.

Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.

Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face

Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills and fever 100.4.

2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.

About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.

Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Patient reports nausea, very extreme and sudden, chills, mild fever (100.5 degrees) and extreme fatigue.

Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.

Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadryl, symptoms resolved soon after.

sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour later. all considered mild but wanted to report for tracking.

1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal

Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.

Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.

Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pain, chills, and joint pain on the third day and lasted around six hours. Loss of appetite and nausea lasted about a week. Tiredness and headache lasted almost two weeks.

Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.

Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.

acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.

headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue

5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.

After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.

Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs; This is spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on the left arm first dose on 16Dec2020 06:00 (lot number: EK57303121) and second dose on 07Jan2021 16:45 (lot number: EL3246) at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 08Jan2021 05:00 AM, the patient experienced chills, body aches, nausea, vomiting, fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs. No treatment was received for the events chills, body aches, nausea, vomiting. The events resulted to a doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies to medications, food, or other products. Outcome of the events was recovering.

Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.

Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and headache around 10am 1/12. Cough and fever developed by 4pm 1/12, cough was mild and fever never exceeded 101 degrees Fahrenheit. Also experienced fatigue and body aches. Nausea successfully treated with promethazine. All symptoms dissipated significantly or gone altogether around 1am 1/13.

Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.

Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea

Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.

Less than 2 min after administration developed throat fullness and difficulty swallowing. This persisted. Never any wheeze, never any SOB

On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.

Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17

10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER

AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER

About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.

Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.

Sunday evening developed lower pelvic pressure which continued to Tuesday. Called my OB MFM office and was instructed to come in for a check up. I am currently 18wks 4 days (was exactly 18 weeks on date I received dose 2). At the OB MFM clinic I was discovered to have a shortened cervix of 2cm. I did not have this occur in my prior term pregnancy. Although there may be no causal link I felt it important to report as there may be an association with the vaccine and cervical length/risk of preterm delivery.

5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone

Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.

Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.

arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.

within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.

14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.

Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.

Tiredness; muscle and joint pain; muscle and joint pain; injection site pain; nausea; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; multiple swollen lymph nodes in the side of neck that are painful and the size of llama beans, nickels and dimes; I fell like I have a bad flu; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Ek5730, intramuscularly in left arm on 18Dec2020 10:30 AM at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none, no known allergies. The patient didn't have COVID prior vaccination. Concomitant medication in 2 weeks included ibuprofen, phentermine, paracetamol (TYLENOL), valacyclovir. The patient didn't have other vaccine in four weeks. The patient experienced tiredness, muscle and joint pain, injection site pain, nausea, multiple swollen lymph nodes in the side of neck that were painful and the size of llama beans, nickels and dimes. She felt like she had a bad flu. Adverse events start date was 02Jan2021 08:30 AM. It was unknown if treatment was received for the events. COVID was not tested post vaccination. Outcome of the events was recovering. The patient received the second dose of BNT162B2, lot number: Ek9231, intramuscularly in left arm on 08Jan2021, 06:15 PM.

pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.

Chills, major body aches, nausea, massive headache, tiredness from 4am to 3:30 pm 1/21/21. Around 11 am, I was get to find some stregth to get out of bed and take some Ibuprofen.After that time minor fatigue, minor muscle ache and headache. In the morning of 1/22/21 about 7am feeling 50% better. About noon about 90% better.

Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.

Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came home and went to sleep after vaccine . Achy spine, front of my head hurt, nauseous. Same 2nd day. 3rd day just achy spine. Slept on and of last few days. Did not call Dr. Or go into office because symptoms didnt worsen. I work in hospital and kept in contact with EHO on monitoring steps i needed to take.

Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior vaccination so have MD visit later today for the nausea and rash/itching.

Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in the AM had severe headache, nausea, malaise, muscle aches, soreness at injection site

Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.

While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called to her side. Her BP was elevated and she remained pale & dizzy. She was taken to ED. No medications were administered.

Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.

12 hours after receiving the first dose I started having chills. Shortly after that I begin to experience nausea vomiting bodyaches dizziness headache and arm soreness. This lasted for approximately 24 hours. After that symptoms went away except for arm soreness which lasted for a few more days.

12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea

About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.

Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch. The other symptoms resolved after 24 hours.

Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.

Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins felt nauseous- got something to eat since didn't eat before- felt better throughout the day until around 3 pm. That is when my arm was very sore and pain down my right leg. This pain increased throughout the evening and other joints were affected including hips shoulders sternum, knees and ankles- overall body aches. Difficulty sleeping due to pain. Low grade fever of 99.9. Tuesday: 1-5-2021 Very sore arm but went away by midafternoon. about 5:30pm started having stabbing stomach pains that came and went throughout the night. Heat applied to help a little bit. Low grade fever 99.6 Wednesday: 1-6-2021 Woke up with some stomach pain but not stabbing. Still had body aches and still not able to sleep through the night (this is uncommon for me- i sleep hard through the night)- Keft work early due to not feeling well. Temp 99.9 Thursday: 1-7-2021 Tired, body aches, still some stomach issues, not able to sleep through the night Friday:1-9-2021 Tired, stomach feels unsettled, body aches, up again throughout the night Saturday: 1/10/2021 Tired, no energy, stomach feel nauseous at times, body aches still present- tried to get some sleep during the day as well Sunday: 1-11-12021 Tired, still not restful sleep, bodys aches, chills, temp 99.9 Monday: 1-12-2021 Woke up in pain throughout body, some nausea, fever comes and go with high of 99.9 and low of 97.8. Chills with the higher temp., Emotional unable to stop crying for no reason (maybe because I'm not getting sleep?) Took 1/2 day of PTO due to not feeling well. headache Tuesday: 1-13-2021 Took PTO all day Pain throughout the body, nausea, exhausted, still not able to sleep all the way through the night- up multiple times for multiple hours, trying to get sleep thoughtout the day but still not getting a lot. Wedensday: 1-14-2021 Took PTO, continued body aches, stomach issues, no fever Thursday: 1-14-2021 Body aches, stomach pain and issues, no fever as of yet, headache,

2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve

Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left posterior cervical) x 72 hours

Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history

Nausea and dropped to the floor. Nurse Alert called. Upon UC RN arrival, patient awake and alert. Advised she was pregnant and having morning sickness. Tolerated juice and crackers and discharged.

DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)

Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours

Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms

Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.

Pfizer-BioNTech COVID-19 Vaccine diarrhea, headache, fatigue, general feeling unwell approx. 20 hours post initial vaccination lasting a week and a half. Still not completely well. diarrhea x 1 and a half weeks. headache still ongoing.

palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.

First 2 days after 2nd dose I felt chills, body aches, headache, fatigue, day 9 still extremely exhausted exhausted, no appetite, body aches, unable to function for more than a few minutes at a time.

Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged

Report of body aches, HA, nausea, dizziness, fever and vomiting 1 day post vaccination. Treatment: Ibuprofen Outcome: symptoms resolved, No interference with ADL.

Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting between 12am-10:30am. After the vomiting subsided I was able to take Tylenol for the fever and all symptoms resolved.

45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.

Body aches and sweats, headache, joint aches, muscle pain in the neck, fatigue and vomiting (once) . My temp was up to 102. Last about 24 hours.

1/29/21 4:26p received 2nd vaccine 8:10p became extremely tired 1/30/21 awoke to low grade temp, pain, swelling, red injection site, headache; rest of the day tiredness, chills, muscle & joint pain, nausea. Taking Tylenol for pain 1/31/21 awoke to low grade temp, tiredness and enlarged right under arm lymph node, size of an egg, very sore, injection site remains red, tender to touch and swollen, taking Tylenol for pain As of 12:49p no temp

12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose

Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date. Information on the Lot/Batch Number has been requested.

Pfiser-BioNTech Covid 19 vaccine EUA Fever 99.5 , muscle aches, diarrhea & chills lasting approx. 24 hours

Pfizer-BioNTech COVID-19 vaccine EUA- night of 1/5/21 began having joint and muscle pain with sore throat & HA. These symptoms continued and nausea, dizziness, fever and mild nasal congestion start 1/6/21

13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.

Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolved within 12 hours

I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.

Had nausea and some diarrhea yesterday. Feels much better today with slight diarrhea. She took Milk of Magnesia with improvement.

(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department

Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hurt, and no appetite. The fever broke over night. The following day I had hardly any appetite, brain fog, and exhaustion.

Fatigue - within one hour Injection site soreness - 4 hours later Upset stomach/stomach pain/diarrhea- within four hours, still present after 23 hours

Fever / Chills / Headache / Nausea all started on the same day as vaccine around 7pm. Resolved after 36hours. On 1/29 noticed rash from mid neck to shoulder to upper torso, breast, ears. Red and splotchy but not itchy. Rash resolved by 1/30 after a dose of Benadryl.

Flu like symptoms first 2 days: body and headaches, nausea. Tuesday, Wednesday felt better. Thursday 101.0 fever

severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.

Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. Vaccine 2: Nausea, diarrhea, fatigue, severe body and muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.

Headache, Chills, Nausea, Fatigue, Muscle Aches. I slept for approximately 18 hours with really bad chills.

Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.

12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.

Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.

Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.

5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to the floor near syncope. Laid down and took off mask for air. Was offered water and Benadryl. Drank some water then felt better.. Refused the Benadryl. 10 minutes after someone noticed a possible rash on my forehead. Went ahead and took some Benadryl. Later that night had same feelings.. fast heart rate and dizziness. The next day development flu like symptoms with fever up to 102.9. Took a half Tylenol. The next day just felt achy . The day after that had diarrhea.

Later on that day of vaccination around 7:00pm my head started to hurt. The next day I had a headache, nausea, chills & muscle ache. The headache lasted about 5 days & the nausea & chills lasted for 1 day & the muscle aches lasted about a day or 2. I did a consult over the phone but I didn't had to go in.

Had low grade fever, chills, red hot ears, headaches, slight body aches that following night after receiving vaccine. The next day, had headaches nauseous for short time then hit with serve body ache, fever, and headaches.

2/12/21. Vaccine at 5:30 AM Symptoms started same day. ~12 PM: Sore arm. ~4 PM: Light headed and headache. 6 PM: Loss of appetite. 8 PM: Achey + feverish (took Tylenol) 2/13/21. 2 AM: Feverish, aches, chills, headache, stomach ache (took more Tylenol). 8 AM: All symptoms persist, loss of appetite continues, spent day in bed, taking Tylenol every 6-8 hours. 8 PM: Starting to feel a bit better. Hungry for first time. 2/14/21. 8 AM: Woke up feeling fairly normal. More tired than usual during the entire day. Appetite gradually returned over course of day.

chest tightness and nausea, hyperventilation, 1st dose pfizer vaccine @ 1610, benadryl 25 mg IM given

I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.

Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.

smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.

I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site and flush face the rest of the date. On Saturday, the 13th, I was fatigued, extreme arm pain at injection site, flush face, and cold all day. Sunday, the 14th, much the same as Saturday until evening when extreme dizziness and diarrhea set in. Woke up in the night with extreme dizziness and nausea. All day Monday, 2/15, I had lethargy, lightheadedness, dizziness, flush face, body aches and chills. Tuesday, 2/16, same exact symptoms as Monday. Wednesday, 2/17 was still mild body aches and flush face. Thursday, lesser body aches but still flush face. Today, 2/19, I still have flush face and fatigue.

could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.

Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen

Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light headed. BP 142/98, P 100 at 10:16am. Placed on floor with head down/feet elevated. Ice packs applied to neck. Given water to drink. Monitored for 30 minutes with no improvement. BP 112/80 P 80 @ 10:46am. Squad called to transport to ER.

02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pain, headache, exhaustion, slight nausea, joint pain 02/16/2021 - 02/17/2021: extreme fatigue, joint pain 02/18/2021 - 02/24/2021: fatigue, joint pain (7 on a scale of 1-10)

per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body

tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

13:10-Patient on gurney in observation after vaccine for hx of nausea/lightheadedness with 1st dose of vaccine x 1.5 days. PMHx: HTN, Gastroparesis, IBS Meds: Flagyl, Glyburide VS: B/P-148/110, RR 16, SaO2: 96% on RA, CBG: 133 1327 repeat VS: B/P-138/104, RR 16, HR 90, SaO2: 98% on RA Cool cloths to neck and forehead with HOB flat. Slight improvement. Daughter accompanied patient today is able to drive her home. 1415: patient released by Provider on duty and EMS. Patient educated to follow up if her symptoms should worsen. Patient communicated understanding at time of discharge home with daughter.

13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o lightheadedness. Patient alerted observer and medical assistant called for transfer of the patient to the first aide office. Patient then evaluated by EMS on duty: VS: b/p 142/80, SaO2 100% on RA. PMHx: Migraines Medications: Fiornial, patient had same s/sx after 1st vaccine. 1435: Patients symptoms resolved and patient was cleared by EMS to discharge home. Ambulated on own without weakness. Escorted out by Paramedic to car.

1st vaccine 1/31/21; 2nd vaccine 2/21/21; developed N/V/D, HA, chills onset 2/21/21 after vaccine; seen at ICC 2/26/21 for ongoing symptoms; sent to ED from ICC 2/26/21 for treatment of symptoms.

Patient after receiving her vaccine stated she felt dizzy and lightheaded with nausea immediately. Patient taken to first aide area for assessment. Patient is A & O x3, Skin Pink warm and dry and patient appeared in no apparent distress. Patient states she has a history of migraines. Patients VS were: B/P 130/66, HR 89, SaO2 of 95% on RA. Patient stated that she did have a headache with 6/10 pain and states her last migraine was last one week ago with no aura. Patient discharged home after full 30 minute wait without complications and return to baseline.

felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.

extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off

Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.

Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 29Jan2021 17:15 (at the age of 42-years-old) at single dose for COVID-19 immunization in the workplace clinic. Medical history included endometriosis, acid reflux, and history of blood clots. The patient had no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. Concomitant medication included methyldopa hydrochloride (ALDOMET [METHYLDOPA HYDROCHLORIDE]), omeprazole (PROTONIX [OMEPRAZOLE]), probiotics (PROBIOTICS), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and vitamins. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the left arm on 08Jan2021 at 06:15 PM (at the age of 42-years-old) for COVID-19 immunization. The patient did not receive other vaccines in four weeks. The patient experienced extreme muscle aches, fever, chills, headache, vomiting on 30Jan2021 at 11:00 AM. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch number has been requested.

First dose I was exhausted, body aches, high fever and headache. The 2nd dose I had dry heaves and headache.

Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then. I am very worried about the second shot

nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. Lay down for 45 minutes and observed. symptoms spontaneously subsided.

Diarrhea; severe abdominal pain; This is a spontaneous report from a non-contactable nurse. A 42-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EN5318; expiration date: unknown) at vaccination age of 42-year-old via an unspecified route of administration in the right arm on 31Jan2021 at a single dose for covid-19 immunization. Medical history included Pcos (polycystic ovaries). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 vaccine; lot number: EL3246; expiration date: unknown) at vaccination age of 42-year-old intramuscular in the left arm on 11Jan2021 09:00 AM at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 01Feb2021 12:00 PM, the patient had diarrhea and severe abdominal pain staring 24 hours post second vaccine which lasted for 24 hours. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The events were non-serious. The outcome of the events was recovered on 02Feb2021 12:00. No follow-up attempts are possible. No further information is expected.

Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I'm experiencing remind me of those: bloody sto, diarrhea, nausea, bloating, stomach cramping. The symptoms started about 30 minutes after the vaccine was administered. It took me this long to figure out it may have been the vaccine. (The above is my main concern. I did also experience a stiff and painful arm which limited my range of motion, and fever. But I expected those reactions. )

The next day of the vaccine on 1/13/2021 around 4am I had fever, chills, body aches, joint aches, nauseous, fatigue, headaches & I had diarrhea for 1 day. All my symptoms lasted for about 3 days except the body aches they lasted for about 5 days. I called my primary doctor he prescribed me antibiotics. After a week is when I felt normal.

I got the first dose of the Pfizer vaccine on Weds (3/3) at 9am. As I was driving home I noticed the left side of my face was numb which stopped after a period of time but ever since I have been having similar numbness on my cheeks and cheekbone. I am also having pretty bad stomach pain. It started Thursday night at 1am and has continued. It started as cramping through my entire tummy and now its burning in my stomach area. I also woke up with a migraine today. Also having chills sweating and fatigue

03/07/2021: After 15-45 mins of receiving vaccine, felt dizzy and light-headed sensation, which subsided after 1 hour. Later in the evening, around 19:00 pm; skin started feeling itchy which lasted overnight and adhoc period the next day - would describe ad mild to moderate. presented as fine rash on stomach and tors, itchy back, arms, face around cheeks and jaw line, and ankles. Also felt slightly nauseas from around 10pm on 03/07/2021. On 03/08/2021: Skin itchiness continued, describe as mild. Called Primary care doctor who recommended taking 1 Zyrtec per day to alleviate the itching; registering the adverse reaction, and seeing an allergist prior to considering taking the second dose of Pfizer.

Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.

Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips

Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.

Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose. Nurses put me in wheelchair and took me to bed. Kept me for 30 mins. Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.

08:03- Vaccine administered at Hospital in ED. Observation time increased to 30 minutes related to history of anaphylaxis. 08:18- Pt complains of difficulty swallowing and feeling as though throat swelling. Patient placed on monitor. O2 sat 98-100% on room air. Epi 0.3mg administered in left outer thigh at this time. 09:21- Patient continued to be monitored in ED but not registered as an ED patient. Patient denies needing to be seen by provider. Symptoms resolved. Patient states "I'm fine. I'm better than fine, I'm great." 09:25-Patient discharged from observation. Instructed to return to ED or call 911 if symptoms return. Patient voiced understanding.

Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.

My arm was sore right away. I got a headache and felt queasy several hours after getting the vaccine. I had a difficult time eating dinner and threw up later in the evening. The next day, my sinuses were stuffed up and I still had a headache.

sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that. Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose tip feels like it?s freezing and has numbness and a runny suddenly on day 3.

10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies difficulty breathing or throat closing. Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm

Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.

unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Patient reported to vaccination site for second dose of Pfizer BioNTech vaccine; received vaccine at approximately 1:34. Approximately 1:48 patient reported feeling lightheaded and nauseated. Vitals taken 1:50pm 139/99, HR80 resp 16 O296, 1:55pm 146/99, HR84, resp 18, O297, 2:00pm 145/88, HR85 resp18 O298 2:05pm 139/89 HR61 resp18, O298 2:10 pm 134/89 HR71 resp 16 O299% 2:15pm 135/82 HR75,O2 99, 2:20pm 131/87, HR70, O2 99, 2:28pm 130/76, HR69 O2 99% Patient reported headache and sweating, dizziness and nausea continued. EMS called and arrived at 2:28pm. Patient transported by EMS to hospital.

Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.

~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.

Around 10:30pm, about 12 hours after receiving the 2nd injection (no adverse reaction to first), I woke up with chills, body aches, and a headache. I also had nausea that came in waves. After the 1st shot, I had minor injection site soreness, but the 2nd shot had soreness and periodic sharp shoulder pain. All symptoms and general fatigue continued throughout Tuesday, the day after the shot. All symptoms subsided Wednesday, except the arm was still sore, with less periodic sharp pain and occasional pain in the left armpit.

Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours, the spotting increased to a light bleeding with fatigue and cramping in the abdomen and has remained this way. I am still currently bleeding. My last period ended 3/7/21. My period is never irregular.

Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,

Patient started vomiting about 8 min. after vaccine administration. Her vitals were normal and she decided she wanted to wait another 5 min. but she was fine afterwards. No issues prior

Immediately after injection patient was light headed, drowsy, nauseous. Patient was given water and glucose tabs (potential low blood sugar) and rested with head down. Even after rest patient still complained head was "fuzzy" and seemed dazed. EMTs were called and patient was taken to local hospital for follow up care.

Light headache and body ache nausea after shot. Then fever started that evening and severe body aches, twitching, headache, nausea, chills

Within minute of the injection, patient had severe headache. She had dizziness and became very fatigued. She could not stand up and it was hard to understand her. Within 10 minutes of the injection, patient became very nauseated. They brought her a trash bucket and she hd dry heaved twice. Pharmacist called the EMT around 6pm. The two EMTs took her blood pressure and pulse. Both were extremely high. Blood pressure was 172/96. They recommended that patient should be transported to local ER at the hospital. They put her in the ambulance andtransported her to hospital. She remained at the hospital for 5 hours. Once blood pressure and pulse came down, she was allowed to leave.

Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.

Starting about 12 hours after the shot I got chills a high fever, all over body aches and began vomiting. I vomited repeatedly for about 6 hours and could not even keep water down. I was concerned that I might have to go to the emergency room. The following morning I felt a bit better. No longer nauseous, just mild body aches, headache and fatigue. By 48 hours all symptoms were gone.

Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, short gray hair) was standing when she administered the vaccine, and I remember making a note of the whole situation because it was the first time that a nurse did NOT say, ?Relax your arm.? I thought that was odd. I felt nauseous and dizzy within 1-2 min., but after my 15 min. Waiting period was up, I was no longer feeling dizzy or nauseous so I left. Within 10 min. I felt an ache in my arm, deep in the bone, and different then the regular shot-site pain. This is a dull ache that is barely tolerable. A few hours later, my shoulders and neck were experiencing very extreme, sharp pain, and I can barely move my arm, neck, and head. It hurts to hold my head up straight. This pain continues for another 2 days. It is a very intense, throbbing ache, and worse after a fitful night of rest, due to the constant pain in my left arm and neck. 48 hours later, still in intense pain and got a massage. Helped briefly but pain returned within minutes. On day 3, I got another more targeted massage on my shoulders and neck, with only a brief amount of time free from the pain. Day 4, the pain is so intense and I can barely handle it. I make an appointment with a APRN. She does not mention SIRVA but prescribes 800mg of Ibuprofen every 4 hours as needed for pain, and Flexeril, a muscle relaxer. She also gave me a shot of Toradol for the pain. The Flexeril makes me drowsy, and the ibuprofen takes the sharp edge of the pain away, but does nothing to mask the dull, deep ache in my left arm and shoulder. Day 5, 6, 7 all the same. On day 7, a new tingling sensation and numbness in my left hand and fingers start. Contacted office again to request a referral for physical therapy, and also to make a note of SIRVA in my file. Got a prescription for a stronger pain medication; neurontin to hopefully make the pain more manageable.

3/22/21 -- vaccine administered at approx 9:35am. Soreness near the injection site in the arm began at approx 4pm. Patient felt significant general fatigue beginning around 7:30pm, a sudden, overwhelming desire to sleep. Around the same time, the patient's upper left arm/shoulder area progressed to being too sore to be able to move the limb independently. Patient felt significant body aches (similar to what is commonly experienced with the flu) and chills by around 11pm and continued experiencing the drastic arm soreness. 3/23/21 -- by 1am, patient experienced mild nausea and also a big headache in addition to the symptoms previously listed. By 7am, the arm soreness had improved significantly, the nausea/chills were gone, but the headache and body aches were still present and significant. By noon, the headache was mostly gone, and the body aches had improved by 50%, and the arm soreness was almost gone. By 5pm, the body aches and headache were finally gone.

Muscle aches and joint pain over 7 days now. I also had some bloating with the injection for a few days after. Symptoms started 30 minutes post injection. I started with headache and fatigue, along with the muscle and joint aches; the joint aches have persisted.

Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100%.

I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.

In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am

Massive headache, dizziness, nausea, throat pain, swelling and bruising around injection site, body aches.

Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Nerve pain, fever, muscle soreness, headache, nausea.

bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 18:00 (at the age of 42 years-old), as single dose for covid-19 immunization. Medical history included diabetes, hypothyroidism, palindrome rheumatoid and known allergies with seafood. Patient is not pregnant at the time of report and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was taking several daily prescription medications. On 25Feb2021 18:30, patient experienced severe GI issues: bloody stool, diarrhea, nausea, bloating and stomach cramping. Symptoms have continued for 8 days now. Patient stated, "It took me this long to figure out it may have been the vaccine". The outcome of events was not recovered. Patient did not receive any treatment for the events. Follow-up attempts are completed. The following information on the batch number has been requested.

like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.

i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.

retested and was found positive; COVID-19 virus test positive; ear infection; sinusitis; Watery diarrhea; feeling sick; The following day I woke up with sinus congestion; Intense muscle aches; Headache; I began with a cough that night; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Batch/Lot Number: Er8727) as SINGLE DOSE; and first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:00 AM (Batch/Lot Number: En6200); both for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Public Health department (also reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (reported as List of any other medications the patient received within 2 weeks of vaccination) included benazepril, hydrochlorothiazide, protonix, oxymetazoline hydrochloride (CLARITIN ALLERGIC) and Methotrexate; all taken for an unspecified indication, start and stop date were not reported. The patient reported that: "On 14Mar2021 at 10:00 PM, I began with a cough that night. The following day (15Mar2021) I woke up with sinus congestion, cough, muscle aches and headaches. The following day the same. I tested negative that day (Nasal Swab on 16Mar2021). The following day (17Mar2021) I received my 2nd dose of vaccine still feeling sick and cough which I informed PH nurse of. Later that night still same symptoms but with watery diarrhea. No stomach cramps or pain to indicate diarrhea. I went the following day (18Mar2021) to my physician and was told I had ear infection and sinusitis. I was given meds. Yesterday morning I woke up with intense muscle aches and headache. I retested and was found positive (Nasal Swab) on 19Mar2021." The outcome of the events was not recovered. It was reported that treatment were received for the adverse event which includes: Amoxocillin, Flonase, albuterol and promethazine. The events resulted Doctor or other healthcare professional office/clinic visit. Further information needed, further information expected.

Began throwing up around 6:00 until 8:00 PM. Then turned into severe stomach pain. Went in on Saturday morning at 10:00 to the ER. They admitted me into the hospital for EMERGENCY SURGERY TO REMOVE MY APENDIX. Appendicitis. Never any issues before. I did research, there have been 7 other people with such severe reactions thus far.

fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband. As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.

During 15 minute waiting period, I started having increased heartbeat and overwhelming nausea. I reported it to the nurse, she took my vitals and my heartbeat was 140-150. My O2 levels were fine and my lungs were clear. Approximately 15 -20 min post vaccine I started having seizures.( I have no history of seizures) I was given Epinephrine, benadryl to calm my body down. It did not change any of my symptoms. I had approx. 5 seizures in the facility before they called the ambulance. I had 3-4 on way to hospital and more once I arrived. I was given ativan to help me relieve the symptoms. I was given a CAT scan and there were no issues as per doctor. I did not have any more seizures and I was sent home. The next morning I had a doctors appointment and started having seizures again. I had about 4 at home, ambulance was called and had more seizures throughout the day. I was admitted to hospital since my seizures were not stopping. I was given another CAT scan and MRI and nothing was was found in either test.

My wife is unable to hear, she has a constant ringing, she has vertigo/dizziness, and nausea. We discovered this after visiting an ENT on Monday, 4/19/21. He said that my wife developed a viral infection in both of her ears, possibly due to the vaccination she received a week earlier.

life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.

Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered. Information on the lot/batch number has been requested.

diarrhea; she tested positive for Covid-19; she tested positive for Covid-19 with fever; This is a spontaneous report received from a contactable nurse (patient herself). A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number/Expiration date: EK5730/Unknown) via an unspecified route of administration in the left arm on 19Dec2020 and second dose (lot number/expiration date: EL1283/Apr2021) via an unspecified route of administration in the left arm on 07Jan2021 at 18:00 (at the age of 42-year-old) as a single dose for COVID-19 immunization at Hospital. Medical history included ongoing Ulcerative colitis from 1997. Patient prior vaccination included flu shot, had a little neuropathy from the flu shot the last couple of times that she received it and the last flu shot was in 2018. Concomitant medications included adalimumab (HUMIRA) at an unspecified dose once weekly from 2008 still ongoing for Ulcerative colitis and was taking immunosuppressants to treat and rabeprazole sodium (ACIPHEX) at a dose of 20 mg once daily (reported as probably 4 years ago) still ongoing for reflux. Patient was a non-smoker. Patient reported that she works in health care and has a daughter with special needs, and she wanted to protect herself so that she did not become a vector for her daughter, and she was definitely symptomatic for Covid-19 and reported that she ran a fever, her highest temperature was 102.6 and stated that she thinks that it's been coming down considerably every day. On 08Apr2021, patient temperature was 100. On 08Apr2021, patient had COVID-19 PCR test and tested positive after receiving both doses of vaccine. It was unknown that patient had SARS-CoV2 antibodies at diagnosis. On 09Apr2021, her temperature was 99. The patient did not require supplemental oxygen or mechanical ventilation and patient did not have multiorgan failure, respiratory, cardiovascular, vascular, renal, neurological, hematological, dermatological symptoms but had gastrointestinal/hepatic symptoms of diarrhea issues but she has been having ulcerative colitis issues and she would not say that the diarrhea issues started when she got sick. The patient did not receive any additional therapies or initiation of a new medication or other treatment or procedure for Covid-19. The outcome of the event she tested positive for Covid-19 was recovering and for diarrhea was unknown.; Sender's Comments: The contributory role of the suspect product to reported events is possible.

upper stomach pain; chills; vomiting all night and diarrhea; vomiting all night; severe back ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 12:00 as a single dose for COVID-19 immunization. Medical history included colitis from an unknown date and unknown if ongoing. Concomitant medication included mesalamine (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccines in four weeks. The patient was tested for COVID-19 with a nasal swab on 04Apr2021 with a result of negative. On 01Apr2021 at 06:00 PM, the patient started to have severe back ache. The patient took Aleve and it didn't go away. The patient then had dinner and took Tylenol extra strength and tried to sleep. The patient took Benadryl to go to sleep as the pain was unbearable. The next day, 02Apr2021, the patient was fine until 09:30 PM. The unbearable backpain came back and the patient also had upper stomach pain. The patient had chills, no fever, vomiting all night and diarrhea. The pain never went away. By Sunday, 04Apr2021, the patient went to the hospital in the emergency room and her gallbladder was removed. The patient was hospitalized on 04Apr2021, for two days, due to the events. The outcome of the events was recovering.

Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite

Symptoms similar to what I actually had Covid last year. Reflux, constant nausea, fatigue, occasional headaches

fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.

flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.

She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.

Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).

fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.

had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22/2020, also felt tired.

sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.

nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID vaccine (brand Pfizer); lot number: 5730; expiration date: unknown), intramuscular left arm on 19Dec2020 11:00 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient had headache about 2 hours (13:00) after vaccination then about 6 hours (17:00) after she had nausea. The reporter considered the events as non-serious which did not result to death, not life-threatening, or did not caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain

Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache

Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided after 7 hours. Intermittent headaches that only last for a few minutes and then subside.

Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin. The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.

Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.

Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.

Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)

Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).

Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after vaccine

Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.

C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED

Rash Back (L) arm chest pruritic Nausea & vomiting. Swelling (L) arm Exam Rash as above external vesicle Txt corticosteroid, antihistamines

Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.

Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; This is a spontaneous report from a contactable other HCP. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 20Dec2020 17:30 at a single dose for covid-19 immunisation. The vaccine was administered in the hospital. Medical history included asthma. The patient was not diagnosed COVID-91 prior to vaccination. There were no concomitant medications. On 20Dec2020 21:00, the patient experienced severe diarrhea for 3-4 hours starting 2 hours after vaccine, fatigue for several days and headache. The outcome of the events was recovered on an unknown date. No treatment was required for the events. The patient was not tested for covid-19 post vaccination. Information about lot/ batch number has been requested.

first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU

Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next morning she had upset stomach, feeling dizzy, thought she was going to faint and a headache.

I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine

Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.

Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.

Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.

8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.

Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report

Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had no appetite and had nausea that would come and go. Decreased exercise for a couple days after. The following Monday I still had some fatigue but felt tired and low level nausea and not really hungry, There were waves when I felt like I was coming down with something. I felt tired enough that I went home early from a shift and tested for Covid. Test came back negative.

5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction

Patient was nauseous, threw up slightly and had a headache. This lasted for about 30 minutes, which occurred about 15 minutes after the vaccine administration. She also had a headache that persisted through till the next day,

Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.

Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.

Severe muscle and joint pain, fatigue, low grade fever for 2 days. Loss of appetite. Treatment Tylenol 650 mg and Ibuprofen 400 mg. Symptoms resolver after 2 days

Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats and having abdominal pain

Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.

about 12 hour after injection chills, fever, bone pain, joint pain, muscle aches, headache, sore throat, nausea. Symptoms lasted about 36 to 48 hours with lingering muscle aches and headache

Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.

intermittent fevers, extreme muscle ache, Left axillary lymphadenopathy for over 24 hours. Took ibuprofen and tylenol which exacerbated stomach ache. Then took sucralfate and esomeprazole and tylenol supp.

received injection before noon, by 1800 reported mild chills. After midnight, chills became worse, temp=101.6. Severe chills 0400, diaphoresis. 0900 body aches, especially back and legs. swollen axillary lymph node on arm of injection. Began vomiting intermittently until 1630. two days post injection awoke fully recovered with exception of tender, swollen axillary lymph node on arm of injection.

About 24hrs later on the 12/24/2020 I started getting a headache it lasted until 12/30/2020. But on 12/27/2020 I stated feeling nauseas & I was vomiting. On 12/30/2020 I had to see a doctor.

Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed

Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection

During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4. Muscle aches mostly to lower back. Felt like back was crushing

Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.

Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%

Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.

approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.

myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne. The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00. The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.

Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration on 09Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included depression, obesity, penicillin and bee sting allergies. The patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID prior to vaccination. Concomitant medications included venlafaxine, cetirizine and ibuprofen. The patient previously took ceftriaxone sodium (ROCEPHIN) and experienced allergies. The patient was given first dose of bnt162b2 on 19Dec2020 18:30 on left arm for COVID-19 immunization (lot number: Eh9899). No other vaccines in four weeks prior to COVID vaccine. On 09Jan2021 18:00, the patient experienced malaise, myalgias, arthralgias, headache, fever and nausea from 12 hours post injection until 36 hours post injection. Treatment was given for the adverse events which included acetaminophen and ibuprofen. The patient has not been tested for COVID post vaccination. The patient was recovering from the events.

About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.

Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.

First 24 hours-body aches and headache, resolved at 48 hours. 48-72 hours felt fine. 72 hours -onset of nausea and severe headache, quickly shifted into diarrhea and two rounds of heavy vomiting (patient rarely vomits even when sick)

I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.

Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.

Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.

I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.

Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.

Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.

Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours

Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and body aches. Day 3 still had some body aches. Day 4 the pt returned to feeling normal.

extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.

Fever of 101.7 F resolving 01/28/2021 around 3pm. Muscle aches, malaise. Better on 01/28/21 Nausea and vomiting started on 01/2721, required IV fluids on 01/28/2021 at approximately 4:30am. Feeling better this afternoon 01/28/2021.

PT developed ST and fever 102.7, nausea and body aches yesterday; she got a second COVID vaccine, Pfizer, 2 days ago, she feels better today, able to eat and drink, but needs tests for work.

Severe nausea/vomiting, SOB, throat swelling, dizziness, headache, chills. HRT recommended ED visit. She had IVF and Zofran. Symptoms improved.

Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

1:15 PM: pt received vaccination. 1:18 PM: pt states her throat feels "thick" and "uncomfortable to swallow". Oxygen saturation: 100% and HR: 85. 1:30 PM: Oxygen saturation : 98%, HR: 69 1:35 PM: Oxygen saturation: 98%, HR: 70. Reports feeling better. Sensation is improving. 1:40 PM: Oxygen saturation: 99%, HR 65, pt reports she feels okay 1:45 PM: Oxygen saturation: 98%, HR 67. 1:50 PM: Oxygen saturation: 98%, HR 70. Pt states she is ready to go and is feeling better. She had no difficulty talking or breathing.

Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort, gases and diarrhea,

Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Profound fatigue/weakness

Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.

01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.

A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throat, painful cough, chills. No fever. On 01/01 I woke up and had no voice. I went straight to the UC and they diagnosed me with upper respiratory infection, I was treated with azithromycin and something else for nausea. About days later I was totally fine.

Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; then extremely loose stools and 1 event of loss of bowel control.; This is a spontaneous report from a contactable Other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 16:00 at single dose in Left Arm for COVID-19 immunization. The patient medical history was not reported. There were no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). There were no other vaccines received in four weeks. The patient did not have COVID-19 prior vaccination and COVID-19 was not tested post vaccination. The patient experienced Fatigue, headache, constipation, then extremely loose stools and 1 event of loss of bowel control on 13Jan2021 17:00, no treatment received for these events. The outcome of the events was unknown.

Post vaccine-developed swollen lymph node under Left arm, headache, nausea, lethargy. This resolved by day three. Day 4 started having periods of extreme vertigo, this is happening more frequently and with more severity up to today 2/2/2021 woke with severe dizziness and nausea, fell over when rising from bed. continue to be very dizzy and nauseated

Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up head. Feet numb bilaterally. Nausea. Exhaustion. All lasting 24 hours. Profuse sweating as well for last 8 hours. kidney pain. I have never experienced such pain in my entire life.

severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142) on 12Jan2021 at 12:00 pm at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included high blood pressure and celiac disease. Concomitant medications included unspecified high blood pressure medicine. On 12Jan2021 at 20:00 patient experienced severe diarrhea, stomach cramping, nausea, vomiting, fatigue and headaches. This lasted 10 days so far (as reported). The events were reported as non serious. Treatment received includes Antacid, anti-nausea medication and immodiome. At the time of the reporting the patient had not yet recovered from the events.

Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.

Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4

This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 15Jan2021 07:40 at a single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medications were not reported. The patient reported that she was having some side effects from the second dose of the Covid vaccine. On 15Jan2021, within 1 hour, the patient started having a low-grade fever and very nauseous. Also, the patient stated that she "feels awful". She didn't experience this with my first dose. The outcome of the event feels awful was unknown, while the outcome of low-grade fever and very nauseous was not recovered.

Headache; diarrhea; nausea; lethargy; This is a spontaneous report from a contactable other healthcare professional (hcp reported for self). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot EK9231, expiry date not reported), via an unspecified route of administration on 16Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included known allergies to poultry and egg. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included ethinylestradiol, norethisterone (CYCLAFEM 0.5/35), riboflavin (VIT B2), colecalciferol (D3), magnesium, and bifidobacterium lactis (PROBIOTIC); all reported as other medications in two weeks. Patient had no other vaccine in four weeks. On an unspecified date in Jan2021 (also reported as 03Jan2021; pending clarification), the patient experienced headache, diarrhea, nausea, and lethargy continued after 4 days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events headache, diarrhea, nausea, and lethargy were not recovered.

Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.

I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.

Prolonged fatigue, nausea, low grade fever, lightheadedness 4 days after 2nd dose and still present 14 days after vaccine dose

Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.

Headache; Nausea; extreme Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration at the left arm on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient medical history includes chronic kidney disease. The patient was not pregnant from the time of administration. The patient was taking numerous unspecified medications. The patient previously took amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced allergy. On 21Jan2021 at 04:30 PM the patient experienced headache, nausea and extreme diarrhea. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in doctor's office/urgent care. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.

Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approximately four hours post-injection. Symptoms lasted (and increased in intensity) for approximately 72 hours.

Stomach became upset roughly 3 hours after the vaccine was administered along with fatigue. The following day I was fine but then had repeats of the symptoms over the weekend and even still today (Monday after the vaccine.)

Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 min later, restless, can?t stay still, moaning. Muscle cramping getting worse in abdomen. Get up to get more water and urinate, starting to salivate as if going to throw up. Lean over toilet for 20 min, burning hot , weak, throw cold water around face and neck. Take another Advil, lay back down in bed, muscle convulsions for next 20 min, slowly dissipating. Entire episode took 3 hours. Felt like worst period cramping with fever on top of food poisoning. Next day was mildly nausea and sore, tired.

Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.

Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.

SEVERE ACHING IN MUSCLES AND JOINTS. FEVER UP TO 102 X 2 DAYS. POINT TENDERNESS TO ENTIRE BODY. COULD NOT WALK FOR 6 HOURS (MUSCLE WEAKNESS), CONFUSION, DIZZYNESS, HEADACHE, ABDOMINAL PAIN, CHEST PAIN, SHORTNESS OF BREATH.

At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after she recieved her first dose of Pfizer BioNTech COVID-19 vaccine EUA. Viitals taken every 5 minutes. Patient then reports that she is feeling heavyness in her body, nausea, and started to feel "warm coming from the inside." 5: 45pm Administered 50 mg of Benadryl by mouth. Patient initially declined meds. Monitored patient for one hour. Patient was alert and oriented and left clinic with her friend.

Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swallowing. Lasted about 30 minutes. Two days later my right leg felt dead and big, similar feeling to when I had a spinal for a cesarean section. The sensation was off and on for 2 days and then subsided.

pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%

Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills and body aches.